Argon Medical Devices Recalls MicroStic Plus Sheaths Due to Dilator Hub Defect
Argon Medical Devices is recalling 200 units of MicroStic Plus sheaths because the dilator hub is too small to secure the dilator to the sheath.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a structural defect in a medical device used for vascular access, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Argon Medical Devices, Inc. is recalling 200 units of MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F. These products are sheaths used to facilitate placing a catheter through the skin into a vein or artery.
The supplier initiated the recall because the affected lots have an outer diameter of the dilator hub that is slightly smaller than is capable of securing the dilator to the sheath. The affected product codes are 11149662, 11151447, 11151617, and 11149822.
The products were distributed worldwide, including to the United States (specifically Tennessee and Mississippi) and Canada. The source text does not specify instructions for consumers or healthcare providers regarding the disposition of these units.
The recalled product
- Product
- MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F. A sheath used to facilitate placing a catheter through the skin into a vein or artery.
- Manufacturer
- Argon Medical Devices, Inc
- Category
- Medical Device — Vascular Access
- Affected units
- 200
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- 11149662
- 11151447
- 11151617
- and 11149822.
Distribution
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